Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (NCT NCT06226545)
NCT ID: NCT06226545
Last Updated: 2026-03-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Day 1-Day 253
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
Randomized Low-dose LASN01 (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of 300 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Open-label High Dose LASN01 (Post-teprotumumab, US Only)
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
9
|
15
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
Baseline characteristics by cohort
| Measure |
Randomized Low-dose LASN01 (Anti-IGF-1R-naïve TED)
n=9 Participants
Participants received intravenous infusion of 300 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=8 Participants
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
n=9 Participants
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Open-label High Dose LASN01 (Post-teprotumumab, US Only)
n=15 Participants
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.31 • n=68 Participants
|
48.0 years
STANDARD_DEVIATION 16.60 • n=69 Participants
|
50.4 years
STANDARD_DEVIATION 14.48 • n=137 Participants
|
53.4 years
STANDARD_DEVIATION 56 • n=565 Participants
|
50 years
STANDARD_DEVIATION 13.87 • n=127 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
8 Participants
n=137 Participants
|
11 Participants
n=565 Participants
|
32 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
4 Participants
n=565 Participants
|
9 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
2 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
3 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
2 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
White
|
8 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
5 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
8 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
8 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
29 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
2 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
3 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
1 Participants
n=69 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
0 Participants
n=137 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
2 Participants
n=565 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
3 Participants
n=127 Participants • Two participants reported their race as "Other". One in the Randomized high-dose LASN01 group and one in the Open-label high dose LASN01 group. They have been included in the "Unknown or Not Reported" count in the appropriate group.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
4 Participants
n=565 Participants
|
14 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
5 Participants
n=137 Participants
|
10 Participants
n=565 Participants
|
26 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
1 Participants
n=127 Participants
|
|
Study Eye Iris Color
Black
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
2 Participants
n=565 Participants
|
3 Participants
n=127 Participants
|
|
Study Eye Iris Color
Blue
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
2 Participants
n=565 Participants
|
5 Participants
n=127 Participants
|
|
Study Eye Iris Color
Brown
|
5 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
5 Participants
n=137 Participants
|
9 Participants
n=565 Participants
|
24 Participants
n=127 Participants
|
|
Study Eye Iris Color
Hazel
|
2 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
4 Participants
n=127 Participants
|
|
Study Eye Iris Color
Gray
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
2 Participants
n=127 Participants
|
|
Study Eye Iris Color
Green
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
3 Participants
n=127 Participants
|
|
Study Eye Iris Color
Other
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 253Population: Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
Outcome measures
| Measure |
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=9 Participants
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Pooled Active (300mg and 600mg)
n=17 Participants
Participants received intravenous infusion of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|
|
Percentage of Participants Showing a Response in Proptosis Measured Using Hertel Exophthalmometer (≥2 mm Decrease From Baseline) in the Study Eye and Separately in Either Eye Without Increased Proptosis (≥2 mm Increase) in the Other Eye
|
3 Participants
|
—
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 393Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
Outcome measures
| Measure |
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=8 Participants
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
n=9 Participants
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Pooled Active (300mg and 600mg)
n=9 Participants
Participants received intravenous infusion of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|
|
For Randomized Treatment Arms: Number of Participants With Adverse Events Receiving LASN01 Compared to Placebo
|
6 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 393Outcome measures
| Measure |
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Pooled Active (300mg and 600mg)
n=15 Participants
Participants received intravenous infusion of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|
|
For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
|
—
|
—
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1-Day 253Population: Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
Outcome measures
| Measure |
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=9 Participants
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Pooled Active (300mg and 600mg)
n=17 Participants
Participants received intravenous infusion of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|
|
Percentage of Participants Showing a Response in Clinical Activity Score (CAS) in the Study Eye Compared to Baseline as Assessed by CAS Evaluation
|
4 Participants
|
—
|
15 Participants
|
Adverse Events
Randomized Low-dose LASN01 (Anti-IGF-1R-naïve TED)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Randomized Placebo (Anti-IGF-1R-naïve TED)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Open-label High Dose LASN01 (Post-teprotumumab, US Only)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Low-dose LASN01 (Anti-IGF-1R-naïve TED)
n=9 participants at risk
Participants received intravenous infusion of 300 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=8 participants at risk
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
n=9 participants at risk
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Open-label High Dose LASN01 (Post-teprotumumab, US Only)
n=15 participants at risk
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
Other adverse events
| Measure |
Randomized Low-dose LASN01 (Anti-IGF-1R-naïve TED)
n=9 participants at risk
Participants received intravenous infusion of 300 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized High-dose LASN01 (Anti-IGF-1R-naïve TED)
n=8 participants at risk
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
Randomized Placebo (Anti-IGF-1R-naïve TED)
n=9 participants at risk
Participants received intravenous infusion of LASN01-matching placebo once every 4 weeks for up to 13 infusions
|
Open-label High Dose LASN01 (Post-teprotumumab, US Only)
n=15 participants at risk
Participants received intravenous infusion of 600 milligrams of LASN01 once every 4 weeks for up to 13 infusions
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
13.3%
2/15 • Number of events 3 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Brain Fog
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Nerve Compression
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Parosmia
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
General disorders
Asthenia
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
22.2%
2/9 • Number of events 2 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
26.7%
4/15 • Number of events 4 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 2 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 4 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
13.3%
2/15 • Number of events 2 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 3 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Eye disorders
Ulcerative keratitis
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Skin and subcutaneous tissue disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Eye disorders
Blepharitis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 2 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Eye disorders
Iritis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Infections and infestations
Genital candidiasis
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
6.7%
1/15 • Number of events 2 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Investigations
Sinus rhythm
|
11.1%
1/9 • Number of events 1 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
12.5%
1/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/8 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
11.1%
1/9 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
0.00%
0/15 • Adverse Event data was collected from signing of informed consent through the end of follow-up, up to 57 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place